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NCT Number: NCT07027475

Acute Treatment and Long-term Assessment of Adult Infectious Meningitis

Prospective, multicenter, observational clinical registry of adult patients with acute infectious meningitis across approximately 30 public and private hospitals in Brazil. The study will include adults, 18 years old and older, with suspected acute infectious meningitis. Data will be collected during hospitalization and post-discharge to evaluate clinical management, treatment and short and long-term outcomes. The study aims to generate real-world evidence on current practices and outcomes to support improvements in national care protocols.

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Key information

About this study

This is a middle-income real-world prospective clinical registry study. Clinical and laboratory data will be collected during hospitalization and follow-up visits after discharge.

Data collection will include empirical antibiotic therapy timing and type, time from hospital admission to antibiotic's first dose, corticosteroid therapy initiation, vaccination status per the Brazilian National Immunization Program, neurological sequelae and access to specialized rehabilitation services post-discharge.

Primary outcome will be all-cause mortality. Secondary outcomes will be length of hospital stay, rate of re- hospitalization, sensorineural hearing loss incidence, etiology-specific mortality, functional outcomes (measured by modified Rankin Score and Barthel Index Brazilian version), guideline-based therapies by etiology, neurological sequelae incidence stratified by etiology (e.g., motor deficits, cerebrovascular complications), adverse events, incidence of use of post-meningitis assistive devices and access to rehabilitation.

Findings will be used to inform public health system and clinical care in Brazil.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Both sexes, aged ≥ 18 years, meeting one or more of the criteria (A, B or C) below:

--> Criterion A: Clinical presentation compatible with a suspected case of meningitis or meningococcal disease:

Fever ≥ 37.8 °C (axillary) associated with at least two of the following:

  • Severe headache
  • Vomiting
  • Altered level of consciousness (confusion, drowsiness, irritability)
  • Photophobia
  • Seizure OR Fever associated with one of the classic signs of meningeal irritation (neck stiffness, Kernig or Brudzinski signs) OR Sudden-onset fever with petechial rash or hemorrhagic suffusions
  • Criterion B: Cerebrospinal fluid with leukocytes ≥ 5 cells/mm³ (corrected for red blood cell count at 1:500)
  • Criterion C: Confirmed etiological diagnosis of meningitis or meningococcal disease with no more than 48 hours between pathogen confirmation and signature of the informed consent form by the participant or legal representative.

Exclusion criteria

  • Refusal to provide consent for the study.
  • Presence of a neurological condition, other than meningitis, that accounts for the current clinical picture.
  • Clinical, laboratory or radiological evidence of an alternative infectious focus that accounts for the current clinical picture.
  • Use of an intraventricular device prior to study inclusion.
  • Etiological diagnosis of meningitis or meningococcal disease confirmed more than 48 hours earlier.

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: Day 28

    The primary outcome is the incidence of all-cause death

Secondary outcomes

  1. Re-hospitalization

    Time frame: Day 28

    Incidence of all-cause re-hospitalization

  2. Length of hospital stay

    Time frame: Day 28

    Length of initial hospital stay (measured in days)

  3. Invasive ventilatory support

    Time frame: Day 28

    Incidence of invasive ventilatory support

  4. Adverse Events

    Time frame: Day 28

    Incidence of adverse events

  5. First dose of antibiotic therapy

    Time frame: Day 28

    Time from hospital admission to administration of the first dose of antibiotic therapy

  6. Sensory hearing loss

    Time frame: Day 28

    Incidence of sensory hearing loss

  7. Patients with guideline-directed therapy

    Time frame: Day 180

    Proportion of patients receiving empirical and targeted therapies according to national meningitis management guidelines

  8. Mortality in six months

    Time frame: Day 180

    Incidence of all-cause mortality

  9. Length of hospitalization by etiology

    Time frame: Day 180

    Length of hospitalization (in days), stratified by infectious etiology

  10. Re-hospitalization rate

    Time frame: Day 180

    Rate of all-cause re-hospitalization

  11. Access to specialized rehabilitation services

    Time frame: Day 180

    Proportion of patients receiving specialized rehabilitation care

  12. Re-hospitalization rate by etiology

    Time frame: Day 180

    Rate of unplanned re-hospitalization stratified by etiology

  13. Neurological sequelae by etiology

    Time frame: Day 180

    Incidence of neurological sequelae stratified by etiology

  14. Post-discharge functional decline

    Time frame: Day 180

    Functional status decline assessed on follow-up using Functional independence measured by modified Rankin Score ≤ 2 and Barthel Index (Brazilian version)

    Functional status will be assessed using two standardized measures: the Modified Rankin Score (mRS) and the Barthel Index (Brazilian version). Decline in functional independence will be categorized as follows:

    • Mild disability: defined by an mRS score of 0 to 2 and a Barthel Index score of 90 or higher, indicating independence or slight dependence in daily activities.
    • Moderate disability: defined by an mRS score of 3 and a Barthel Index score between 60 and 89, corresponding to moderate dependence requiring some assistance.
    • Severe disability: defined by an mRS score of 4-5 and a Barthel Index score below 60, reflecting severe dependence or bedridden status with the need for constant care.
  15. Adverse outcomes requiring secondary intervention by etiology

    Time frame: Day 180

    Incidence of adverse outcomes by etiology

  16. Post-meningitis assistive devices

    Time frame: Day 180

    Incidence of use of post-meningitis assistive devices (hearing aid; ambulation support - wheelchair, walker; nasoenteral tube or gastrostomy; ventilatory support; limb prosthesis; low-vision assistive device; cerebrospinal fluid shunt device);

Study contacts

Contact information is provided by the study sponsor or research team.

Anna M Gomes, MD

CONTACT

[email protected]

+55 11 2151-1233

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

Prospective Clinical Registry of Acute Treatment and Long-term Assessment of Adults Meningitis

Acronym: ATLAS-I

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jun 18, 2025
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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